Medicine
Dexmedetomidine 200 mcg/2 mL injection
Dexmedetomidine 200 mcg/2 mL injection is a generic prescription medicine for intravenous use, made by 14 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted 15° to 30°C (59° to…
Key facts
- Active ingredient (INN)
- Dexmedetomidine
- Brand
- Sold under the generic name
- Strength
- 200 mcg/2 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 2 mL, 5 vials of 2 mL, 10 vials of 2 mL and 20 more
- Manufacturers
- Piramal Critical CareIndiaAccord HealthcareIndiaEugiaIndiaGland PharmaIndiaSun Pharmaceutical IndustriesIndiaMedical Purchasing SolutionsBaxter HealthcareFresenius KabiProPharma DistributionAvenacy
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05CM18 Dexmedetomidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 August 2014
- Identifiers
- RxCUI 309710, 1718906, 1718909DailyMed set ID 6937235f-ea25-4950-e053-2991aa0a9b74, 1896a96e-25f8-494e-9a96-6463b52fb102, 8fa36783-b94d-4084-8c41-40ee64192074 +18NDC 71872-7122, 65219-642, 71288-505 +18Application ANDA202126, ANDA201072, ANDA204843 +7
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, glass in 1 carton / 2 mL in 1 vial, glass | 66794-230-42 | Piramal Critical CareIndia | 19 January 2021 |
| 25 vial, glass in 1 carton / 2 mL in 1 vial, glass | 66794-233-42 | Piramal Critical CareIndia | 1 May 2021 |
| 25 vial in 1 carton / 2 mL in 1 vial | 16729-239-93 | Accord HealthcareIndia | 21 December 2016 |
| 25 vial in 1 carton / 2 mL in 1 vial | 55150-209-02 | EugiaIndia | 17 March 2016 |
| 25 vial in 1 carton / 2 mL in 1 vial | 68083-527-25 | Gland PharmaIndia | 28 June 2021 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 57664-596-50 | Sun Pharmaceutical IndustriesIndia | 8 April 2015 |
| 25 vial in 1 tray / 2 mL in 1 vial | 63323-421-02 | Fresenius Kabi | 18 September 2015 |
| 25 vial in 1 tray / 2 mL in 1 vial | 65219-642-02 | Fresenius Kabi | 13 December 2024 |
| 5 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 36000-262-05 | Baxter Healthcare | 16 April 2026 |
| 10 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 36000-262-10 | Baxter Healthcare | 16 April 2026 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 36000-262-25 | Baxter Healthcare | 16 April 2026 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0143-9532-25 | Hikma Pharmaceuticals | 26 April 2017 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 71288-505-03 | Meitheal Pharmaceuticals | 18 January 2019 |
| 25 vial, glass in 1 carton / 2 mL in 1 vial, glass | 67457-251-02 | Mylan Institutional | 18 August 2014 |
| 25 vial in 1 carton / 2 mL in 1 vial | 42023-146-25 | Par Health | 19 August 2014 |
| 1 vial in 1 bag / 2 mL in 1 vial | 71872-7030-1 | Medical Purchasing Solutions | 28 February 2020 |
| 1 vial in 1 bag / 2 mL in 1 vial | 71872-7031-1 | Medical Purchasing Solutions | 2 March 2020 |
| 1 vial, single-dose in 1 bag / 2 mL in 1 vial, single-dose | 71872-7122-1 | Medical Purchasing Solutions | 30 March 2018 |
| 1 vial in 1 bag / 2 mL in 1 vial | 71872-7218-1 | Medical Purchasing Solutions | 15 July 2020 |
| 1 vial, glass in 1 bag / 2 mL in 1 vial, glass | 71872-7323-1 | Medical Purchasing Solutions | 22 January 2024 |
| 2 mL in 1 vial, glass | 84549-230-42 | ProPharma Distribution | 10 October 2025 |
| 2 mL in 1 vial, single-dose | 84549-505-03 | ProPharma Distribution | 10 October 2025 |
| 25 vial in 1 carton / 2 mL in 1 vial | 83634-600-02 | Avenacy | 15 March 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Dexmedetomidine 200 mcg/2 mL injection.
Other strengths and forms of Dexmedetomidine
Clinical summary
Dexmedetomidine is a central alpha-2 adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting, among other approved uses. MedsAcross supplies Dexmedetomidine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DexmedetomidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Precedex prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
- Dexdor: European public assessment report (EPAR) · European Medicines Agency
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